Human Papillomavirus (HPV) is a DNA virus from the Papillomaviridae family and Papillomavirus genus, which mainly infects human epidermis and mucosa tissues. About 170 types of HPV been identified, wherein some types of HPV cause warts and cancer after invading the human body, but other HPVs do not cause any symptoms.
HPV can infect humans and animals, and mainly invades epidermis cells and the inner layers of tissues. According to the types of the infected tissues, HPV can be distinguished into epidermis types and mucosa types, wherein the epidermis types mainly induce an infection on the epidermis of the hands and feet, and the mucosa types cause the infection in the mouth, throat, respiratory tract and urogenital tract of patients. HPV causes the proliferation of skin keratinocytes and results in skin warts (such as flat warts, common warts or plantar warts) on the hands or feet. In general, these warts may disappear after 1 to 5—years of infection, but some infected skin may result in skin cancer, and some may result in oral squamous cell carcinoma.
There are 30-40 types of HSV which infect genitalia and the peripheral skin via sexual behavior, and some types of HSV may induce warts on the sexual organs. If a person is repeatedly infected with some types of HPV with high risk and do not induce obvious symptoms (e.g. warts and so on), the invasion of these HPV may develop into precancerous lesions, or even invasive cancer. An HPV infection is one of the key causes of cervical cancer, which is commonly caused by sexual behavior or by mother-to-child transmission. Some research indicates that 99.7% of cervical cancers are caused by HPV infection.
The common methods for detecting HSV-infected cells include a cytologic test and a thin-cytologic test in the early phase. These tests are the traditional manual identification methods, which have the problems of accuracy and timeliness. Recently, DNA detection methods, such as in situ hybridization, HPV DNA direct detection, amplification hybridization, HPV mRNA detection and microarray, have been developed because of breakthroughs in DNA techniques. At present, although molecular diagnostic technology is predominantly used to detect HPV, it is typically paid for the patient's own expense and the cost is high. Although the U.S. Food and Drug Administration (FDA) approved Roche's Cobas® HPV Test (Roche Molecular systems Inc.) as a first-line primary screening tool in April 2014, there is no officially suggested first-line primary screening tool for any age group accepted by many medical associations (e.g. the American Association for Cancer Research (AACR)). In addition, although the Australian authority approved the Cobas® HPV Test as a first-line primary screening tool in some administrative areas in 2015, the Cobas® HPV Test is not highly recommended. Accordingly, the scientific community still uses HPV detection methods such as the image cytologic test which is manually determined. However, there are still problems that cells infected with HPV cannot be quickly and accurately determined.
Furthermore, Pap smears (also called the Papanicolaou test) are determined one by one by pathologists to identify and classify the characteristics of the Pap smears. However, the number of Pap smears has expanded far faster than the number of pathologists. This causes an excessive workload for the pathologists and could affect the accuracy of the identification of Pap smears. Therefore, there is a gear need for digital pathologic screening and diagnostic equipment to identify the HPV-infected cells (such as from the Pap smears) using digital diagnostic screening and diagnosis, to help pathologists identify and classify the characteristics, so that the screening time for the Pap smears can be reduced, while also maintaining the accuracy and reliability.
To sum up the above disadvantages, it is ideal to have new digital pathologic screening and diagnostic equipment and a method to overcome the above-mentioned defects. It is therefore the Applicant's attempt to deal with the many limitations in the prior art.